Chemistry: analytical and immunological testing – Optical result – With claimed manipulation of container to effect reaction or...
Reexamination Certificate
1997-11-17
2001-08-21
Alexander, Lyle A. (Department: 1743)
Chemistry: analytical and immunological testing
Optical result
With claimed manipulation of container to effect reaction or...
C436S174000, C422S051000, C422S067000, C422S105000
Reexamination Certificate
active
06277646
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to a fluid specimen collecting and testing apparatus suitable for field or laboratory use. More particularly, the present invention is directed to an apparatus for collecting and testing biological fluids in a single apparatus while preserving the integrity of the originally collected specimen.
BACKGROUND OF THE INVENTION
In the health-care industry, diagnostic testing of body fluids is a common place activity. Employers, government agencies, sports teams and other organizations have also become increasingly involved in diagnostic testing to maintain safety in the workplace and to ensure compliance with laws, rules and regulations.
It is generally necessary in diagnosing and testing for the presence of a predetermined analyte (e.g. drugs and/or disease) to collect biological fluids from an animal or human, i.e., urine, blood, sputum, pleural, cavity and peritoneal cavity fluids for analysis. Maintaining the integrity of the collected biological fluid specimens is vital to obtaining reliable test results and to preserving an uncontaminated sample for subsequent confirmatory testing. It is of utmost importance during the collection and handling of biological fluid specimens that the potential for specimen contamination be minimized or eliminated. It is also important to minimize the potential for specimen damage during the collection process and testing process.
Many known devices for collecting and testing body fluids involve multiple steps and/or multiple containers. Generally, these devices require collection of a fluid specimen in one device, isolation or segregation of the fluid specimen into an aliquot in the same device and transfer of the specimen to a different device for analysis. Separate collection, and testing requires an undesirable amount of handling of the specimen and is likely to lead to unacceptable levels of contamination.
There is a long felt need in the industry for a unitary device that performs collection, isolation and testing of a specimen that preserves the integrity of a portion of the specimen, isolates a separate portion of the specimen for testing, and minimizes the risk of misidentification. One of the difficulties in realizing such a device is that current federal regulations prohibit mixing the collected specimen with the aliquot specimen or the test specimen. Existing prior art devices that perform collection, isolation and testing have not adequately maintained separation between the collected fluid specimen, the aliquot and the test specimen. These devices have also failed to provide a totally sealed system in that bodily fluids leak to the outside environment. Furthermore, existing prior art devices have experienced undesirably high error rates in their function and in their test results.
SUMMARY OF THE INVENTION
The present invention involves an integrated fluid collection and testing apparatus that may be used with any type of fluid specimen, and is particularly useful for urine, blood and saliva specimens. The apparatus collects a fluid specimen, isolates a predetermined portion of the specimen, and exposes only the isolated portion of the specimen to diagnostic or testing structures and/or reagents. The isolated portion may be isolated as the fluid is collected in the apparatus, i.e., without any additional manipulation by testing personnel. The isolated portion is then independently tested in isolation from the collected fluid specimen.
In accordance with one embodiment of the invention, the fluid specimen collecting and testing apparatus includes a collecting chamber for collecting the fluid specimen, an isolation chamber for isolating an aliquot of the fluid specimen for testing, and a test chamber or region for testing the specimen. In accordance with the invention, the collection chamber is never in fluid communication with or open to the test chamber. Preferably, when the collection chamber is in fluid communication with the isolation chamber, the test chamber is closed to the isolation chamber. When the isolation chamber is in fluid communication with the test chamber, the collection chamber is closed to the isolation chamber. Preferably, the isolation chamber is in fluid communication with the collection chamber so that the aliquot can be readily isolated without complex manipulation by collection personnel. A test chamber is provided for performing diagnostic testing on the aliquot.
Furthermore, in accordance with the invention, the isolated portion of the fluid does not contact the remainder of the collected sample once the isolated portion comes in contact with contaminating structures or reagents. In accordance with the invention, the collected sample is maintained in a pristine or unadulterated state. Such a characteristic of the present invention is advantageous in that it permits independent and/or confirmatory testing of the same sample that was screened using a device of the present invention. Also in accordance with the invention, a totally closed (sealed) system is provided which prevents the fluid specimen from leaking to the outside environments. Other advantages will be clear to those skilled in the art upon reading the description and drawings below.
In view of the importance of testing the aliquot in isolation from the collected fluid specimen, the test chamber is sealed from the collection chamber. To initiate testing, communication between the isolation chamber and the test chamber is established. In a preferred embodiment of the invention, a fluid releasing device is provided that opens the communication between the isolation chamber and the test chamber and establishes a fluid flow path to the test chamber. To prevent undesirable flow through the collected fluid specimen to the test chamber via the isolation chamber, the fluid releasing device may also establish a seal between the collecting chamber and the isolation chamber.
In accordance with another aspect of the present invention, the specimen container may include a tamper evident lid which provides an identification of whether or not the container has been opened which may indicate that the contents of the container have been compromised. In a preferred embodiment, a tamper strip may be releasably attached to the tamper evident lid which, in combination with the specimen container, permits one way rotation of the lid. Removal of the lid after closure to the locked position preferably results in partial or complete disconnection of the tamper strip from the lid. This feature reduces the possibility of sample adulteration and aids in ensuring the integrity of the diagnostic testing.
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Guirguis Raouf A.
Haldopoulos Dean
Harmison Brian K.
Pratt Michael R.
Alexander Lyle A.
Dade Behring Inc.
Jordan Leland K
Ruszala Lois K
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